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Prospective Registry of Exposure to Gepotidacin (PREG)

2026年9月29日 更新者:GlaxoSmithKline

Prospective Registry of Exposure to Gepotidacin (PREG): a Prospective Registry of Women and Their Offspring Exposed to Gepotidacin During Pregnancy

The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital malformations (MCMs) and small for gestational age (SGA), as well as to evaluate secondary maternal, fetal, and infant outcomes.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

観察的

入学 (推定)

614

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

15年~50年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

Pregnant participants with uncomplicated urinary tract infection who are exposed to gepotidacin or standard-of-care antibiotics during the relevant exposure window.

説明

Inclusion Criteria:

For Both cohorts:

  • Participants with aged 15 to 50 years
  • United States resident
  • Currently pregnant
  • Participants personally signed and dated informed consent document or, upon waiver of written consent by the relevant Institutional review board (IRB), verbal consent indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study
  • Authorization and contact information for the reporter (e.g., participant, maternal/infant Health care provider (HCP), prescriber) to allow for follow-up

Exposed cohort:

• Exposed to gepotidacin at any time during pregnancy or the relevant exposure window

Comparator cohort:

  • Diagnosis of and treatment for uUTI at any time during pregnancy or the relevant comparator product exposure window
  • Exposed to one or more American College of Obstetricians and Gynecologists (ACOG)-recommended treatments for acute cystitis at any time during pregnancy or the relevant comparator product exposure window

Exclusion Criteria:

For Both cohorts:

• Diagnosis of known MCMs for the index pregnancy prior to enrollment

Exposed cohort:

• None

Comparator cohort:

• Exposure to gepotidacin at the time of enrollment

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
Exposed cohort

Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to gepotidacin during the relevant exposure window

Not Applicable since Observational Study

他の名前:
  • 観察研究
Comparator cohort

Pregnant participants with uncomplicated urinary tract infection (uUTI) who are exposed to standard-of-care antibiotics during the relevant exposure window

Not Applicable since Observational Study

他の名前:
  • 観察研究

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of infants with major congenital malformations (MCMs)
時間枠:At pregnancy outcome, with follow-up through 12 months after delivery

An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.

At pregnancy outcome, with follow-up through 12 months after delivery
Number of infants with small-for-gestational-age births (SGA)
時間枠:At live birth

A newborn infant whose birth weight is less than (<) 10th percentile for sex and gestational age using standard growth charts for full- and preterm live-born infants.

At live birth

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of infants with minor congenital malformations
時間枠:At live Birth, with follow-up up through 12 months of age

An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual.

At live Birth, with follow-up up through 12 months of age
Number of participants (pregnant women) with pregnancy termination
時間枠:From date of conception (DOC) to <20 gestational weeks

A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or because of fetal abnormalities.

From date of conception (DOC) to <20 gestational weeks
Number of participants (pregnant women) with spontaneous abortions (SAB)
時間枠:From date of conception (DOC) to <20 gestational weeks

An involuntary fetal loss or the expulsion of the products of conception occurring at less than (<) 20 gestational weeks.

From date of conception (DOC) to <20 gestational weeks
Number of participants (pregnant women) with stillbirths
時間枠:From 20 weeks' gestation to pregnancy outcome

Stillbirth is defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at greater than or equal to (>=) 20 weeks of gestation, or, if gestational age is unknown, a fetus weighing >=350 grams.

From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with preeclampsia
時間枠:From 20 weeks' gestation to pregnancy outcome

Preeclampsia is disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term, and proteinuria, or, in the absence of proteinuria, it is defined as new-onset hypertension with the new onset of any of the following: Thrombocytopenia: platelet count <100,000/milliliter (mL). Renal insufficiency: serum creatinine concentrations >1.1 milligram per deciliter (mg/dL) or a doubling of the serum creatinine concentration in the absence of other renal disease. Impaired liver function: elevated blood concentrations of liver transaminases to twice the normal concentration. Pulmonary edema. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses or visual symptoms

From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with eclampsia
時間枠:From 20 weeks' gestation to pregnancy outcome

New-onset tonic-clonic, focal, or multifocal seizures in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use.

From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with gestational hypertension
時間枠:From 20 weeks' gestation to pregnancy outcome

Blood pressure greater than 140 millimeter of mercury (mmHg) systolic or 90 mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal.

From 20 weeks' gestation to pregnancy outcome
Number of participants (pregnant women) with gestational diabetes
時間枠:At pregnancy outcome

Any degree of glucose intolerance with onset or first recognition during pregnancy.

At pregnancy outcome
Number of participants (pregnant women) with preterm births
時間枠:At live birth, if occurring before 37 gestational weeks

Preterm birth is defined as a live birth occurring at <37 gestational weeks.

At live birth, if occurring before 37 gestational weeks
Number of infants with postnatal growth deficiency
時間枠:At 4 and 12 months of infant age

Weight, length, or head circumference in <10th percentile for sex and chronological age using standard growth charts

At 4 and 12 months of infant age
Number of infants with developmental delay
時間枠:At 4 and 12 months of infant age

Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention.

At 4 and 12 months of infant age

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • スタディディレクター:GSK Clinical Trials、GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月30日

一次修了 (推定)

2032年8月19日

研究の完了 (推定)

2032年8月19日

試験登録日

最初に提出

2026年9月11日

QC基準を満たした最初の提出物

2026年9月29日

最初の投稿 (実際)

2026年9月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月30日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 300392

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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